Document control system management for medical device QMS. Covers document numbering, version control, change management, and 21 CFR Part 11 compliance. Use for document control procedures, change control workflow, document numbering, version management, electronic signature compliance, or regulatory documentation review.
document control
document numbering
version control
change control
document approval
electronic signature
21 CFR Part 11
audit trail
document lifecycle
controlled document
document master list
record retention
Quality Documentation Manager
Document control system design and management for ISO 13485-compliant quality management systems, including numbering conventions, approval workflows, change control, and electronic record compliance.
Implement document control from creation through obsolescence:
Assign document number per numbering procedure
Create document using controlled template
Route for review to required reviewers
Address review comments and document responses
Obtain required approval signatures
Assign effective date and distribute
Update Document Master List
Validation: Document accessible at point of use; obsolete versions removed
Document Lifecycle Stages
Stage
Definition
Actions Required
Draft
Under creation or revision
Author editing, not for use
Review
Circulated for review
Reviewers provide feedback
Approved
All signatures obtained
Ready for training/distribution
Effective
Training complete, released
Available for use
Superseded
Replaced by newer revision
Remove from active use
Obsolete
No longer applicable
Archive per retention schedule
Document Types and Prefixes
Prefix
Document Type
Typical Content
QM
Quality Manual
QMS overview, scope, policy
SOP
Standard Operating Procedure
Process-level procedures
WI
Work Instruction
Task-level step-by-step
TF
Template/Form
Controlled forms
SPEC
Specification
Product/process specs
PLN
Plan
Quality/project plans
Required Reviewers by Document Type
Document Type
Required Reviewers
Required Approvers
SOP
Process Owner, QA
QA Manager, Process Owner
WI
Area Supervisor, QA
Area Manager
SPEC
Engineering, QA
Engineering Manager, QA
TF
Process Owner
QA
Design Documents
Design Team, QA
Design Control Authority
Document Numbering System
Assign consistent document numbers for identification and retrieval.
Numbering Format
Standard format: PREFIX-CATEGORY-SEQUENCE[-REVISION]
Example: SOP-02-001-A
SOP = Document type (Standard Operating Procedure)
02 = Category code (Document Control)
001 = Sequential number
A = Revision indicator
Category Codes
Code
Functional Area
Description
01
Quality Management
QMS procedures, management review
02
Document Control
This area
03
Human Resources
Training, competency
04
Design & Development
Design control processes
05
Purchasing
Supplier management
06
Production
Manufacturing procedures
07
Quality Control
Inspection, testing
08
CAPA
Corrective/preventive actions
09
Risk Management
ISO 14971 processes
10
Regulatory Affairs
Submissions, compliance
Numbering Workflow
Author requests document number from Document Control
Document Control verifies category assignment
Document Control assigns next available sequence number
Number recorded in Document Master List
Author creates document using assigned number
Validation: Number format matches standard; no duplicates in Master List
Revision Designation
Change Type
Revision Increment
Example
Major revision
Increment number
Rev 01 → Rev 02
Minor revision
Increment sub-revision
Rev 01 → Rev 01.1
Administrative
No change or letter suffix
Rev 01 → Rev 01a
See references/document-control-procedures.md for complete numbering guidance.
Approval and Review Process
Obtain required reviews and approvals before document release.
Review Workflow
Author completes document draft
Author submits for review via routing form or DMS
Reviewers assigned based on document type
Reviewers provide comments within review period (5-10 business days)
Author addresses comments and documents responses
Author resubmits revised document
Approvers sign and date
Validation: All required reviewers completed; all comments addressed with documented disposition
Comment Disposition
Disposition
Action Required
Accept
Incorporate comment as written
Accept with modification
Incorporate with changes, document rationale
Reject
Do not incorporate, document justification
Defer
Address in future revision, document reason
Approval Matrix
Document Level 1 (Policy/QM): CEO or delegate + QA Manager
Document Level 2 (SOP): Department Manager + QA Manager
Document Level 3 (WI/TF): Area Supervisor + QA Representative
Signature Requirements
Element
Requirement
Name
Printed name of signer
Signature
Handwritten or electronic signature
Date
Date signature applied
Role
Function/role of signer
Change Control Process
Manage document changes systematically through review and approval.
Change Control Workflow
Identify need for document change
Complete Change Request Form with justification
Document Control assigns change number and logs request
Route to reviewers for impact assessment
Obtain approvals based on change classification
Author implements approved changes
Update revision number and change history
Validation: Changes match approved scope; change history complete
Change Classification
Class
Definition
Approval Level
Examples
Administrative
No content impact
Document Control
Typos, formatting
Minor
Limited content change
Process Owner + QA
Clarifications
Major
Significant content change
Full review cycle
New requirements
Emergency
Urgent safety/compliance
Expedited + retrospective
Safety issues
Impact Assessment Checklist
Impact Area
Assessment Questions
Training
Does change require retraining?
Equipment
Does change affect equipment or systems?
Validation
Does change require revalidation?
Regulatory
Does change affect regulatory filings?
Other Documents
Which related documents need updating?
Records
What records are affected?
Change History Documentation
Each document must include change history:
| Revision | Date | Description | Author | Approver |
|----------|------|-------------|--------|----------|
| 01 | 2023-01-15 | Initial release | J. Smith | M. Jones |
| 02 | 2024-03-01 | Updated workflow | J. Smith | M. Jones |
21 CFR Part 11 Compliance
Implement electronic record and signature controls for FDA compliance.
Part 11 Scope
Applies To
Does Not Apply To
Records required by FDA regulations
Paper records
Records submitted to FDA
Internal non-regulated documents
Electronic signatures on required records
General email communication
Electronic Record Controls
Validate system for accuracy and reliability
Implement secure audit trail for all changes
Restrict system access to authorized individuals
Generate accurate copies in human-readable format
Protect records throughout retention period
Validation: Audit trail captures who, what, when for all changes
Audit Trail Requirements
Requirement
Implementation
Secure
Cannot be modified by users
Computer-generated
System creates automatically
Time-stamped
Date and time of each action
Original values
Previous values retained
User identity
Who made each change
Electronic Signature Requirements
Requirement
Implementation
Unique to individual
Not shared between persons
At least 2 components
User ID + password minimum
Signature manifestation
Name, date/time, meaning displayed
Linked to record
Cannot be excised or copied
Signature Manifestation
Every electronic signature must display:
Element
Example
Printed name
John Smith
Date and time
2024-03-15 14:32:05 EST
Meaning
Approved for Release
System Controls Checklist
Access Controls:
Unique user ID for each person
Password complexity enforced
Account lockout after failed attempts
Session timeout after inactivity
Audit Trail:
All record creation logged
All modifications logged with old/new values
User identity captured
Date/time stamp on all entries
Security:
Role-based access control
Encryption for data at rest and in transit
Regular backup and tested recovery
See references/21cfr11-compliance-guide.md for detailed compliance requirements.
